FDA Nod For GNMK, AKRX Gets New CEO, PTI Plunges After-hours

(RTTNews) - Today's Daily Dose brings you news about FDA nod for GenMark Diagnostics' ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel; Akorn appointing a new CEO, and pipeline update of Proteostasis Therapeutics.

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Shares of Akorn Inc. (AKRX) were up more than 4% in after-hours, following news of appointment of Douglas S. Boothe as president and chief executive officer effective January 1, 2019.

Most recently, Boothe served as the president of the $600 million generics division of publicly held Impax Laboratories, which was acquired by Amneal Pharmaceuticals LLC in a reverse merger transaction in May 2018. Prior to that, Boothe was the executive vice president and general manager of Perrigo Company Plc. He also served as the CEO of Actavis Inc., the U.S. manufacturing and marketing division of Actavis Group, and held senior positions at Alpharma and Pharmacia Corp.

Shares of Akorn have been moving downhill ever since the Supreme Court of the State of Delaware, on December 7, upheld the lower court's decision to allow Fresenius Kabi AG to terminate the April 2017 merger agreement. Following the disappointing ruling, the then CEO Raj Rai had announced his decision to relinquish the post.

AKRX closed Thursday's trading at $3.62, down 3.98%. In after-hours, the stock was up 4.97% to $3.80.

GenMark Diagnostics Inc. (GNMK) has been given the go-ahead by the FDA to market ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel.

The panel, together with the ePlex Blood Culture Identification Gram-Negative (BCID-GN) and Fungal Pathogen (BCID-FP) Panels, were developed for the diagnosis and disease management of bloodstream infections (BSI) that can lead to sepsis.

The BCID-GN and BCID-FP Panels were submitted to the FDA in September 2018 and are still currently under review.

While announcing its third quarter 2018 financial results on October 29, GenMark reconfirmed its full year 2018 revenue guidance of $68 to $72 million. Revenue in 2017 was $52.5 million.

GNMK closed Thursday's trading at $3.93, down 4.38%. In after-hours, the stock was up 8.14% to $4.25.

Shares of The Medicines Co. (MDCO) were up more than 5% in Thursday's extended trading on no specific news.

A SEC filing dated December 18 reveals that Mark Timney, who recently took over reins as the Company's CEO, acquired 26,863 shares on December 17, at an average price of $18.6o per share.

MDCO closed Thursday's trading at $17.80, down 4.86%. In after-hours, the stock was up 5.11% to $18.71.

Proteostasis Therapeutics Inc. (PTI) now expects to report complete efficacy and safety data from a phase I study of its proprietary combination therapy triplet (PTI-808, PTI-801, and PTI-428) and from the high-dose doublet study in subjects with cystic fibrosis in the first quarter of 2019.

The Company previously planned to report preliminary results from the triplet study by dose cohort as each dose cohort was completed, beginning with a low-dose cohort.

Studies exploring a proprietary doublet (PTI-808 and PTI-801), and separate studies of PTI-801 and PTI-428 with background SYMDEKO therapy, in cystic fibrosis subjects are underway. Data read-out from all the four studies is expected in the first quarter of 2019.

On December 17, the Company announced a worldwide, exclusive license agreement with Genentech, a member of the Roche Group.

Genentech gains rights to potential therapeutic small molecule modulators from Proteostasis Therapeutics as part of the deal. In exchange, Proteostasis is eligible to receive upfront and milestone payments of over $100 million. Full financial terms, the therapeutic target and disease areas of focus were not disclosed.

PTI closed Thursday's trading at $4.11, down 6.38%. In after-hours, the stock was down 21.90% to $3.21.